Resected liver metastasis from colorectal cancer with curative intent
Conditions
Interventions
A: Live resection
B: At 56 to 84 days after hepatectomy, patients receive 2-hour infusion of oxaliplatin IV and l-leucovorin on day 1 followed by fluorouracil (5-FU) bolus and 46-hour infusion on day
Sponsors
Japan Clinical Oncology Group(JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed liver metastasis of colorectal cancer 2) R0 after resection of both primary and seccondary lesions 3) No extrahepatic disease 4) No prior chemotherapy or radiotherapy 5) No prior radiofrequency ablation or cryotherapy for liver metastasis 6) At 42 to 70 days after hepatectomy 7) Patient age is more than 20 and less than 75 8) PS: 0, 1 9) Organ function is kept 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Multiple cancer patients 2) Pregnant patients 3) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema 4) Psychological disorder 5) Steroid administration 6) Patients must use flucytosine, phenytoin or wargarin potassium 7) Insulin dependent or uncontrollable diabetes mellitus 8) Diarrhea or peripheral neuropathy greater than grade 1 9) Uncontrollable hypertension 10) Unstable angina pectoris, or history of myocardial infarction within six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment compliance at 9 courses after beginning mFOLFOX6 (phaseII) Disease-free survival (phaseIII) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Incidence of adverse events, mode of recurrence | — |
Countries
Japan
Contacts
Public ContactYukihide Kanemitsu
JCOG0603 Coordinating Office Colorectal Surgery Division, National Cancer Center Hospital
Outcome results
None listed